- Frank`s Hospital Workshop
Contents
1. 5 Manual Analyzer for CombiScreen 11SYS analyticon urine test strips V4 2 3 revised 3 2009 Contents Contents 2 1 1 Methodology of the Urine test 2 1 2 The test 3 1 3 Intended USS 3 2 Description Of the 4 Qe PACKING Installation 7 4 Operation 9 4 1 Switching 9 4 2 Overview of the MENU 9 4 9 10 4 31 10 43 2 Edit a WOTKIIST 10 11 4 4 1 12 AAA 13 4 5 13 4 51 Setup MENU 13 4 5 1 1 Output SUNS 14 Printer 14 4 5 1 1 2 Serial 5 14 4 5 1 1 3 Language 4 22 42 122 14 4 5 1 2 Strip OPTIONS2. 15 4 5 1 2 1 Measurement 15 4 5 1 2 2 Sensitivity 15 4 5 1 2 3 sequence 04 00 0 16 4 5 1 3 Clock and date 16 4 5 2 17 4 5 2 1 17 4 5 2 2 Calibration 18 4 5 9 A 18 4 5 3 1 Memory 19 4 5 3 2 Clearing data from 19 4 6 Data 20 5 Care of the 21 5 1 Cleaning of the waste 21 5 2 Cleaning Of the CONVEY OF 21 6 Warnings Precautions 22 7 23 8 Technical 24 NS 25 26 Introduction 1 Introduction 1 1 Methodology of the urine test The urinalysis is part of the medical diagnosis methods frequently used by medical doc tors in laboratories in order to reveal diseases The most cost effective device used to screen urine is a reagent test strip This micr
3. Adjust the CombiScan 500 as follows MENU SETUP OUTPUT SERIAL PROTOCOL to PC unidir with a baud rate of 9600 4 Open the CombiScanner Data Management program and follow the instructions in Help menu User s guide See also chapter 4 5 3 1 Memory data transfer Make sure that the baud rate of the selected port of the computer is adjusted to 9600 Care of the instruments 5 Care of the instrument Operation of the CombiScan 500 does not require any special maintenance Only the cover waste bin and conveyor of the instrument have to be cleaned and disinfected regu larly It should be done always after severe contamination at least daily Cleaning should be performed with a wet cloth and or alcohol 5 1 Cleaning of the waste bin The used strips are collected in the waste bin max capacity approx 150 strips which is located under the front door of the conveyor see fig 1 AS soon as the automatic strip counter has reached 150 the demand to empty the waste bin appears on the LCD To open the waste bin slightly push the front side under the conveyor The waste bin will move out automatically Now you can take out the case empty the strips and clean and disinfect the bin with water and alcohol or disinfetant respectively Move the waste bin back into the CombiScan 500 and push it in carefully until it locks in place with a click 5 2 Cleaning of the conveyor It is recommended to clean the conveyor regularly
4. However the system is able to compensate slight deviations From this moment the testing process is controlled automatically by the CombiScan 500 52 gt Fig 7 Positioning of the reagent strip Fig 7a shows the right positioning Fig 7b shows a wrong position E f you are in MANUAL mode you can enter a alphanumeric max 13 digit patient ID to be assigned to the next strip You can enter the digits via the built in numerical keypad or by using a barcode reader or external keyboard Using the WORKLIST mode the next patient s ID appears in the second row of the LCD When a strip has been evaluated the results are sent to the serial port If a computer is connected to the reader the data can be stored and displayed with the Analyti con CombiScanner Data Management software see also section 4 6 If the build in printer is turned on the results are printed out too After dipping the urine strips into the sample they be placed on the conveyor minimum distance of approximately 3cm to the prior strip This allows a throughput of about 500 strips per hour E f you would like to skip a patient ID from the worklist just select the SKIP option and the reader will delete the element and jump to the next item of the worklist or sequence number in manual mode E f during the work you reach the preprogrammed measurement counts defined by the calibration card a warning mess
5. Cleaning of the driving cylinders is necessary weekly or if contaminations are visible on the cylinders and carriage The belts and the support shaft have to be cleaned daily or even more often in case of high number of measurements Please clean the conveyor as follows E Press the CLEAN control key the MENU SERVICE submenu to bring the conveyor in cleaning position Remove all three belts and if necessary also the cylinders Clean the shafts and support by using a wet cloth E Clean the pieces either under running water or alcohol or disinfetant Dry them com pletly and make sure that the inside of the cylinders is dry before putting them back onto the shafts E After the cleaning process is finished replace the belts and cylinders and press OK The display return to SERVICE menu To get back to MENU press the QUIT function key NOTE During the carriage movement Please wait is displayed 21 Warnings Precautions 22 6 Warnings Precautions The CombiScan 500 must be used in the manner described and specified in this manual in order to provide the saftety and performance standards specified The instrument is calibrated for CombiScreen 11SYS test strips With other CombiS creen test strips or with test trips of other manufacturers wrong results will be obtained In order to establish a final diagnosis and prescribe an appropriate therapy the results o
6. be selected PC unidirectional for use of the CombiScan 500 with a host computer with the CombiS canner Data Management software installed All other protocols Labureader MT1 MT2 CL are bidirectional protocols They are need ed if the CombiScan 500 is used in a network environment For more information about using the CombiScan 500 in a network contact your distributor 4 5 1 1 3 Language settings Basically CombiScan 500 supports five languages English German Hungarian French and Spanish Selecting this submenu use the T4 keys to select the desired language Press the OK control key to confirm the selected language In the printout Chinese char acters can be selected instead of normal characters If you want to print out the parameter name in Chinese characters press the 1 numeric key of the keypad In the same way you can disable this function The current setting is displayed on the LCD Operation 4 5 1 2 Strip options There are three possible options to be set units pad sensitivity and pad sequence on printout 4 5 1 2 1 Measurement units Results be displayed in different units Use the control keys in MENU SETUP STRIP UNIT submenu to select the desired unit The CombiScan 500 supports the fol lowing measuring units Conventional Arbitrary Conventional Arbitrary SI Arbitrary 4 5 1 2 2 Sensitivity adjustment The CombiScan 500 provides semiquanti
7. built in magnet fixes it in the proper position See fig 4 Fig 4 Installation of the cylinders Installation Install all the three belts onto the cylinders see fig 5 Press the OK key Now the convey or slips back and the door closes automatically Fig 5 Installation of the belts Open the printer cover Take the roll of printer paper and insert the roll into its cave Load the free end of the paper into the feeding slot in a way that the outer side of the paper roll is facing down while inserting it into the feeding slot if the paper is inserted in the wrong way there will be no printout on the paper The paper will be loaded automatically 666 fig 6 To remove the paper just pull out from top side Fig 6 Loading the printer paper Printer Cover Printer Paper Printer Now the CombiScan 500 is ready to work Note Before the first measurement calibration process should done see section 4 5 2 2 Operation 4 Operation 4 1 Switching on off Connect the CombiScan 500 with the power adapter to a power socket Press the EN TER button if the instrument is in standby mode The name and software version of the instrument is displayed on the LCD for a short time Now one of the following alternative options will be executed depending on the stored working history of the reader E The strip counter is not equal to zero This means that measurem
8. do the calibration manually select MANUAL The conveyor will move back into the housing Now you can enter the 16 digit number which is printed below the first barcode As soon as all numbers are entered the code evaluation and calibration process takes place automatically Details of stored cali bration data will be printed out To interrupt calibration select CANCEL or press the QUIT button 4 5 3 Memory The CombiScan 500 stores the last 999 results in memory With the results the se quence number entered patient ID time and date of measurement are stored as well In this MENU MEMORY submenu you can clear results from memory or transfer stored data to the built in printer or to a device connected to the serial port i e host computer To achieve the functions mentioned above follow the flowchart below Operation 2004 08 09 19 19 26 MENU MEMORY TRANSFER CLEAR TRANSFER REPORTS CLEAR MEMORY gt 036 1234567890123 gt 036 1234567890123 040 2004 08 11 040 2004 08 11 OK 1 OK TRANSFER REPORTS CLEAR MEMORY 036 4110100135674 036 4110100135674 gt 040 2004 08 11 gt 040 2004 08 11 OK OK TRANSFER REPORTS CLEAR MEMORY 036 036 040 040 PRINT SEND OK TRANSFER IN PROGRESS MEMORY CLEAR REPORT 5 CANCEL TRANSFER COMPLETE 4 5 3 1 Memory data transfer By this option the stored data can be printed or send to a host see section 4 5 Data download In both cases you can select a range
9. of the measurement When the reader is adjusted different from manufacturer setting it will be indicated by asterisks in the footer of the printout 4 5 1 2 3 Pad sequence in printout By default the reader prints out the result in the sequence of the pads physical position but it is also possible to customize the layout 2004 08 09 19 19 26 MENU SETUP STRIP UNIT SENS PADSEQ PAD PRINTING SEQUENCE DEFAULT USER DEFINE DEFAULT SET QUIT PAD PRINTING SEQUENCE REPORT LINE 01 PAD NAME BIL This setup option effects only the printout and data transfer If the PADSEQ option is selected you can restore either the default sequence or set up your own sequence by selecting the SET option Selecting SET you can choose pads in a desired sequence of the printout lines In the second row the line number is displayed and the third line indicates the actual parameter name Using the control keys you can perform changes Pressing the NEXT option will display the next printout line If you select End rep only the previously selected parameters will be printed out When the last line is reached the program returns to PADSEQ submenu NOTE You can not define empty printout lines or the same parameter twice or more times 4 5 1 3 Clock and date settings The built in digital clock enables to store the date and time of the measurement It is working even if the reader is turned off or the power supply
10. or patient ID press enter to go to the next ID When using a barcode reader you automatically jump to next ID after you have entered a new ID To go back to the main menu press the QUIT button If you press the BACK control key you will come back to worklist menu where you can print out the worklist If you wish to start the measurement of the first ID of the worklist quit the worklist menu and start measurement from main menu 4 3 2 Edit a worklist A compiled worklist can be edited as well You can edit the IDs add new items or remove single items or the whole worklist Inserting a new item into an existing queue is not al lowed To use the worklist features follow the flowchart shown above From MAIN MENU you can enter the worklist menue by selecting WORKLIST If there is no existing worklist the ADD text is displayed on the LCD left side otherwise EDIT By selecting EDIT ADD option you can modify the patient ID data and or enter new items In the WORKLIST CLEAR submenu single items or the whole worklist can be deleted and in WORKLIST PRINT submenu the worklist can be printed out After pressing EDIT ADD control key the worklist appears Using the arrow keys you can navigate through the worklist If you want to modify a patient ID use the DEL function key Operation of the internal keypad to delete the last characters To confirm the new entered ID press ENTER The next worklist item will appear Reaching the last item of
11. sensor The signals are digitalized and this digitalized image is evaluated by the built in program Due to the CCD technology the instru ment is able to distinguish between colour changes caused by reaction of the test pad chemistry and non spe cific colour development caused by the sample Operation is very simple and doesn t require any special knowledge or dif ficult practice When measurement starts the front door opens and the conveyor assembled onto a carriage moves into the measuring position The strip needs to be placed on the conveyor Both the conveyor and the carriage are driven by a DC motor Description of the reader The carriage has three positions Closed The whole carriage is inside of the housing and the Frontdoor is closed This is the stand by or off position Measurement The front of the carriage is ejected of the reader housing in order to let the operator place the strip onto the three belt conveyor E Maintenance The carriage is fully ejected In this position you can remove the belts and cylinders for cleaning CAUTION The carriage movement is controlled by the reader never try to move it manually not even when the reader is stand by or turned off position If the power shuts down when the carriage is ejected or an error occures turn the reader off and on The carriage will find its normal position automatically DC connector Keyboard RS232 Slot Interface Serial
12. 19 19 26 see Setup menu structure CLEAN CALIBRATION PLACE CALIBRATION CARD OR ENTER 1ST BARCODE PLEASE WAIT MANUAL CANCEL MANUAL CALIBRATION CLEAN THE CONVEYOR BELT Code OK CANCEL 2004 08 09 MENU MEMORY 19 19 26 TRANSFER CLEAR CLEAR MEMORY gt 036 1234567890123 040 2004 08 11 OK OK CLEAR MEMORY 036 4110100135674 040 2004 08 11 OK CLEAR MEMORY 036 040 BACK OK TRANSFER IN PROGRESS REPORT 5 MEMORY CLEAR CANCEL TRANSFER COMPLETE 26 Appendix AWVN LO 1 5 ONILNIYd LIND 145 70330 AWIL MAN YSLNA 92 61 61 60 80 7002 3NI430 lt 5 ONILNIYd AONANOAS 198 M90 19 dNLAS NNAW 92 61 61 60 80 7002 0 ALIALLISNAS ALIAILISNAS LIND 198 Linvssd 3NI430 lt ALIAILISNAS OASdVd 5335 LINN dIeLS dNLAs NNAW 92 61 61 60 80 7005 49019 9141 00100 dNLas NNAW 92 61 61 60 80 7002 V 5 SLINN anya 10612 _70001090 0096 135 1904 1143 LSVYHLNOD 440 NO 330 Wd WNIHO 1 0 15 359 1151477 330 90135 SDVNONVI 1 7999 LNdLNO dNLAS NNAW
13. 7 8 100 100 Spec gravity 60 7 96 4 30 4 82 1 33 6 81 4 94 7 100 Urobilinogen 90 4 97 6 83 0 100 89 8 99 1 100 100 For clinical utility 30 test principles expected values limitations reagent compositions of he test pads storage of test strips and special notes instructions concerning test strips pleaser refer to the package insert of the CombiScreen test strips
14. 9 19 26 CombiScan500 2004 08 09 19 19 26 MENU WORKLIST MENU ITEM Nr 0 EDIT ADD CLEAR STOP SETUP SERVICE MEMORY 10 4 3 Worklist The worklist is a predefined sequence of samples The worklist contains maximum 128 patients ID s in the sequence of planned evaluation A worklist can be generated through a connected external keyboard or barcode reader The patient ID is a maximum 13 charac ter long string containing either numeric or alphabetic characters 11 the worklist is entered through the internal keyboard only numeric characters are possible If you wish to delete an ID from worklist it can be done in the MENU WORKLIST CLEAR submenu 2004 08 09 19 19 26 gt 004 Combi Scan 500 lt 005 V 4 01 05 WORKLIST START MENU 2004 08 09 19 19 26 MENU WORKLIST ITEM Nr 6 EDIT ADD CLEAR PRINT EDIT ADD WORKLIST 2004 08 09 19 19 26 LIST ITEM 001 EDIT MENU WORKLIST CLEAR ID MILLER JOHN ITEM ALL CLEAR WORKLIST ITEM 001 6 ID MILLER JOHN CLEAR 4 3 1 Add a worklist The worklist can be entered by the internal keypad an external keyboard or barcode reader Connect the keyboard or barcode reader to the keyboard interface connector of the CombiScan 500 and press the left control key of the CombiScan 500 to get to the worklist menu In the EDIT ADD worklist submenu a name or a patient ID of up to 13 characters can be typed or read in If you have finalized one name
15. 92 61 61 60 80 7004 27 Appendix 28 Table of results English Bilirubin Conv neg 1 2 4 mg dl BIL Sl neg 15 35 70 umol Arbitrary neg Urobilinogen Conv norm 2 4 8 12 mg dl UBG Sl norm 35 70 140 200 mol l Arbitrary norm Ketones Conv neg 10 25 100 300 mg dl KET SI neg 1 2 5 10 30 mmol l Arbitrary Ascorbic Conv neg 20 40 mg dl acid 51 0 2 0 4 g l ASC Arbitrary Glucose Conv norm 50 100 250 500 1000 mg dl GLU Sl norm 2 8 5 6 14 28 56 mmol l Arbitrary norm 5 Protein Conv neg 30 100 500 mg dl PRO Sl neg 0 3 1 0 5 0 9 1 Arbitrary 10 50 300 Ery ul BLD Sl neg 10 50 300 Ery ul Arbitrary neg 5 6 7 8 9 5 5 6 7 8 9 pH Arbitrary 5 6 7 8 9 Nitrite Conv neg pos NIT Sl neg pos Arbitrary neg pos Leucocytes Conv neg 25 75 500 Leu ul LEU Sl neg 25 75 500 Leu ul Arbitrary neg Specific Conv 1 000 1 005 1 010 1 015 1 020 1 025 1 030 gravity 51 1 000 1 005 1 010 1 015 1 020 1 025 1 030 SG Arbitrary 1 000 1 005 1 010 1 015 1 020 1 025 1 030 Table of results Chinese Appendix 19272 JR mg dl mol l mg dl mol l mg dl mmol l mg dl g l 1000 56 5 mg dl mm
16. MPORTANT Before using the test strip read carefully the CombiScreen 11 SYS packing insert The meter can only be used with the CombiScreen 11 SYS urine test strip 1 3 Intended use CombiScan 500 is an instrument for measurement of urine test strips CombiScreen 11SYS for in vitro determination of Ascorbic acid Bilirubin Blood Glucose Ketones Leukocytes Nitrite pH Protein Specific Gravity and Urobilinogen from urine These measurements are used in the evaluation of diabetes liver diseases haemolytic diseases urogenital and kidney disorders or metabolic abnormalities For professional use not for self testing Description of the reader 2 Description of the reader The equipment is designed specifically for use in clinical laboratories In its basic instal lation the housing is almost fully closed its physical appearance including colour meets the requirements raised by medical laboratories Its throughput is about 500 test strip evaluations hour Front Waste bin LCD Controll Keys Numeric Keys Function Keys Fig 1 Front view of the CombiScan 500 urine analyzer Cylinder 1 Cylinder 2 Rear Shaft Carriage Strip Pumper Belts Fig 2 Description of the parts for installation The optical system is designed espe cially for evaluation of urine test strips The test strip is illuminated by white light and the reflected light from the reagent strip is detected by a colour CCD
17. Port Firmware Fig 3 Rear view of the CombiScan 500 urine analyzer The used strips are collected in a waste bin located under the conveyor inside the Com biScan 500 capacity about 150 strips If the automatic strip counter reaches 150 you will get a warning message which asks you to empty the waste bin To remove the waste bin just push and release its front panel It will be automatically ejected Pull it out totally empty it and insert it back Slip it gently till it is bumping see section 5 1 On the top side of the CombiScan 500 you can find the built in printer If you open the printer cover by lifting it s front side you will get access to the paper roll cave to load printer paper For loading the printer paper refer to section 3 Installation The interface connectors are located on the back panel The external barcode reader and or keyboard can be connected to the keyboard interface connector The host computer can be connected to the RS232 serial port Description of the reader 2 1 Packing list CombiScan 500 instrument 1 cylinder 2 with gearwheel 6 pes Installation 3 Installation CombiScan 500 is shipped in a carton box Prior to unpacking clear the area where the instrument is to be operated a surface of about 30x50 cm will be needed While handling the package please be cautious of the shipping marks on the box Open the box Cut the tape only leaving the car
18. SA7V1A Power adapter Symbols 10 Symbols SN In vitro diagnosticum Warning Read package insert Serial number Manufacturer This product is conform to the directive 98 79EG dated 27 10 1998 For members of the European Union only According to Guideline 2002 96 EC WEEE this instrument must be recycled profes sionally Please return it to your distributor at the end of the economic lifetime Tested to comply with FCC standards For home or office use ANALYTICON BIOTECHNOLOGIES AG 35104 Lichtenfels Germany Phone 49 64 54 79 91 0 Fax 49 64 54 79 91 30 info analyticon diagnostics com www analyticon diagnostics com 25 Appendix Main menu structure 2004 08 09 MENU WORKLIST ITEM Nr 0 EDIT ADD 19 19 26 CLEAR EDIT ADD WORKLIST LIST ITEM 001 EDIT ID MILLER JOHN 2004 08 09 19 19 26 MENU WORKLIST CLEAR ITEM ALL CLEAR WORKLIST ITEM 001 6 ID MILLER JOHN CLEAR Memory menu structure TRANSFER REPORTS gt 036 1234567890123 040 2004 08 11 TRANSFER REPORTS 036 4110100135674 gt 040 2004 08 11 TRANSFER REPORTS 036 040 PRINT SEND 2004 08 09 gt 004 lt 005 19 19 26 Combi Scan 500 V 4 01 05 WORKLIST START MENU MANUAL 500 2004 08 09 19 19 26 gt 001 lt 000 SKIP STOP SETUP SERVICE MEMORY 2004 08 09 MENU SERVICE
19. To get familiar with these features please follow the flowchart below 2004 08 09 19 19 26 gt 004 Combi Scan 500 lt 005 V 4 01 05 WORKLIST START MENU 2004 08 09 19 19 26 MENU SETUP SERVICE MEMORY 2004 08 09 19 19 26 MENU SETUP OUTPUT STRIP CLOCK 2004 08 09 19 19 26 2004 08 09 19 19 26 2004 08 09 19 19 26 MENU SETUP OUTPUT MENU SETUP STRIP MENU SETUP CLOCK PRINTER SERIAL LANGUAGE UNIT SENS PADSEQ SET 12 24 SEQUENCE 4 5 1 1 Output settings In this submenu you can set the printer the serial port and select the language Select the desired function by pressing the buttons below the displayed menu items 4 5 1 1 1 Printer settings In this submenu you can check and adjust the printer settings By pressing the ON OFF key the status of the printer can be changed In off position the results will be stored in memory and send to the serial port In order to secure the permanent printout quality there is a built in option to adjust the contrast in a range of 0 3 by pressing the CONTRAST con trol key In this way you can compensate varying paper quality Pressing the CONTRAST control key will change the contrast up by one degree Reaching the highest contrast 3 the program will return to 0 4 5 1 1 2 Serial port settings Setting up the serial line is needed only if the CombiScan 500 is connected to a compu ter Connect the serial cable to the computer only if the reader is switched off The follow ing protocols can
20. age will be printed In this case you are still allowed to go on measuring an additional 1 of the named counts Finish your work and perform a calibration process with a new calibration card see section 4 5 2 2 If you do not calibrate the instrument it stops working until a new calibration is performed E After having finished your daily routine press the STOP key The conveyor will stop running Clean the instrument and emty the waste bin 666 section 5 12 Operation Note The following error messages may appear during the measurement process The waste bin is full This message is accompanied by a short beep It means that the waste bin has not been emptied for 150 measurements Interrupt the measurement process and empty the waste bin then continue working The waste bin is out This message is accompanied by short beep It means that the waste bin is not in the right position Maybe it wasn t slipped back completely after emptying or it has been opened accidently A Note All instructions must be followed thoroughly to get accurate results 4 4 2 Result printout The printed sent results contain the following data device type date and time sequence number of the test patient identifier result with analyte names values units markings for pathological values and an end line Before each parameter name the pathological value is marked with an asterisk If one or more result classificatio
21. btained with CombiScan 500 should be verified with other medical and diagnostic re sults To check the performance of the system instrument test strips and to ensure reliable results it is recommended to use control solutions regularly and to record the results Es pecially in the following situations the use of urine controls is highly recommended a at the beginning of the daily routine measurements b if a new bottle of test strips is opened if test results are in doubt d if operators are trained on the system Urine samples should be handled as a potentially infectious liquid The equipment which comes into contact with urine should be disinfected thoroughly after having finished working Always apply safe laboratory practices when operating the CombiScan 500 The CombiScan 500 is an electrical device Take care that no liquids like water urine or disinfectants enter the instrument because this may damage the device or may lead to a dangerous situation for the user Do not open the housing of the CombiScan 500 when connected to power supply In case of problems call your distributor Protect the instrument from extreme temperatures or high atmospheric humidity and keep it out of bright light For measuring keep the specifications concerning temperature 15 30 C and relative atmospheric humidity lt 85 7 Troubleshooting During operation different errors and error messages may appear Below you wil
22. en a strip is moved into the measuring position under the optical unit the reflectance of each reagent pad is measured The light reflected at specific wave lenghts from the test pad depends upon the degree of colour change of the pad which is related to the concentration of the particular parameter in urine The intelligent image analyzer software first detects locates the strip and the pads then based on these colour light wave information the CombiScan 500 reads the reagent areas and the values are calculated automatically Results are stored then printed out by the built in printer and can optionally be sent to host computer via serial connection Introduction 1 2 The test strips The base of the urine analysis is the good quality of the urine test strip These strips have separated pads for each parameter The test pads contain reagents which cause colour changes according to the parameter concentration in the urine The CombiScan 500 is calibrated to CombiScreen 11SYS urine test strips and guarantees accurate results all time The CombiScreen 11SYS urine test strip contains reagents for testing Bilirubin Urobilinogen Ketones Ascorbic Acid Glucose Protein Blood pH Nitrite Leukocytes Specific Gravity Besides the CombiScreen 11SYS the CombiScreen 11SYS PLUS can also be used with this instrument To facilitate reading of the manual the test strip is always named CombiScreen 11SYS in this manual I
23. ents were done since the last waste bin emptying If you empty it now press the YES control key and the strip counter will be set to zero If you do not clear the waste bin from used strips now select In this case the strip counter will not be reset f there are measurement results stored the memory at the day s first power on the programm will offer an option of deleting the memory content CAUTION If you select OK all data stored in memory will be erased Chose this option only if data have been archived printed out or you are sure you don t need them any longer E f the memory is free and the used strip counter is set to zero at the first power on the MAIN MENU appears on LCD 2004 08 09 19 19 26 gt gt 004 Combi Scan 500 lt lt 005 V 4 01 05 WORKLIST START MENU If you want to switch off the reader just press the QUIT button Answer YES when the reader asks for confirmation Now the CombiScan 500 is in standby mode 4 2 Overview of the Menu system The equipment is controlled by a multilevel menu system The bottom line of the four row LCD indicates the actual selectable menu items max 3 at the same time These menu points can be selected by pressing the control key right below Without any selection you will get back to the main menu by pressing the QUIT button 2004 08 09 19 19 26 gt 004 Combi Scan 500 lt 005 V 4 01 05 WORKLIST START MENU 2004 08 09 1
24. er to chapter 5 NOTE During the carriage movement Please wait is displayed 17 18 4 5 2 2 Calibration settings The calibration card is delivered with the reagent strips Each calibration card has in dividual barcode printed on it This code contains test strip related data and the number of measurements that can be carried out after calibration If the number of measurement exceeds the predefined number the reader will stop measuring and a new calibration has to be carried out 2004 08 09 19 19 26 MENU SERVICE CLEAN CALIBRATION PLACE CALIBRATION CARD OR ENTER 1ST BARCODE MANUAL CANCEL MANUAL CALIBRATION Code CANCEL If you select CALIBRATION the conveyor will move to measurement position but the con veyor will run faster than it does in the measuring modus Place the calibration card with the bar code upside on the conveyor It must be placed at right angles to the conveyor ina way that the angle with the barcode is close to the meter Place the card behind the strip bumper close to the carriage Before reaching the optical unit the conveyor will slow down and the sensor reads the code The conveyor starts to move in reverse direction delivering back the calibration card The stored calibration data will be printed out CAUTION throw the calibration card away before the package of strips is completely consumed If the calibration wasn t successful or you want to
25. ide of the first row of LCD see below Otherwise MANUAL is displayed see below To learn more about the worklist refer to section 4 3 By selecting START the door will open and the conveyor will move out to be ready for measuring the samples To stop operation press the STOP control key The conveyor will stop running and slips back position and the door will close The MAIN MENU will be displayed again IMPORTANT The reader will only stop operating if the conveyor is empty The STOP command will only be accepted if the last strip detection and evaluation is over If there is no strip detected for 5 minutes a STOP function will be ex ecuted automatically During operation the following informations are displayed on the LCD WORKLIST Combi Scan 500 MANUAL Combi Scan 500 gt 001 MILLER JOHN gt 001 12345678 000 lt 000 SKIP STOP SKIP STOP 11 4 4 1 Measurement The day to day operation of the CombiScan 500 is easy and will be guided by the fol lowing lines Have the urine test sample tubes prepared E Press the START control key Insert an unused strip into the urine specimen rinse it at the edge of the container briefly dap the edge of the test strip on a tissue paper and place it on the conveyor with the test pads upside Push the strip gently till it bumps against the strip bumper The strips must be positioned at right angles to the conveyor see Fig 7a 7b
26. is not connected The reader supports different date and time formats 2004 08 09 19 19 26 MENU SETUP OUTPUT STRIP CLOCK 2004 08 09 19 19 26 MENU SETUP CLOCK SET 12 24 SEQUENCE 2004 08 09 19 19 26 ENTER NEW DATE amp TIME gt gt gt Operation By selecting the MENU SETUP CLOCK submenu you can check the actual settings By pressing the 12 24 control key you can change between 12 and 24 hour time format The SEQUENCE option allows you to change the format of the date By selecting the SET option you can adjust the correct date and time In this submenu use the gt gt gt control key function pad to move the cursor to the position you want to change Enter the correct numbers with the internal keypad or the control keys Move the cursor to the rightmost position to leave this submenu If you press now the QUIT button you will get back to main menu 4 5 2 Service This submenu allows you to perform a new calibration and to clean the conveyor Press the SERVICE button and operate according to the flowchart For calibration there is a calibration card enclosed to the test strips 4 5 2 1 Cleaning It is recommended to clean the conveyor regularly The belts and the support shaft have to be cleaned daily or even more often in case of high number of measurements 2004 08 09 19 19 26 MENU SERVICE CLEAN CALIBRATION PLEASE WAIT CLEAN THE CONVEYOR BELT OK For cleaning of the instrument ref
27. l find the Troubleshooting list of error messages and some suggestions what to do Error Error source Solve the problem E 11 E 17 Hardware error Contact your local distributor E 18 CMOS memory error Contact your local distributor E 19 Hardware error Firmware ERROR Upgrade with an invalid firmware E 19 Try again with a valid one Incompatible firmware version 21 22 Improper test performance due Clean the conveyer belts and to false positioning of the test perform the test again Take care strip or because of contaminated of the strip position see section belts 4 4 2 25 Missing strip improper strip Use a proper test strip E 31 Calibration error Perform a new calibration E 33 Barcode error improper barcode Enter a valid barcode entered 41 Validity calibration error expired Perform new calibration calibration card E 51 Data communication error Check connection cable or the communication settings E 60 Carriage mechanical error Some Disconnect and reconnect the obstruction on the carriage path and the carriage can not reach the right position Incorrect con trol signal reception from the sensor power supply If the error stands contact your local distributor The waste bin is full The waste bin has not been emp tied for 150 measurements Empty the waste bin The waste bin is out The waste bin is not in the right po
28. n limits see section 4 5 1 2 2 for changing sensitivity have been changed the bottom line of result starts and ends with an asterisk Each classification range has a name and a unit corresponding to the analyte Date ur INALYSIS Scan500 Sequence Nr 2004 08 20 10 16 10 10 ter John Patient ID 56 1 000 LEU neg NIT neg pH gt ERY 300 Ery ul PRO neg Values are displayed in conventional units Py 50 n t Pathological values are marked with an as ASC 20 mg dl neg terisk UBG AOFM BIL neg E If one or more result classification limits have been changed the bottom line of re sult starts and ends with asterisk Note The printing on thermal paper fade during storage or if it is covered with transparent tape 4 5 Menu The MENU offers the opportunity to adjust the instrument according to individual require ments and to manage the data in memory To carry out operations select the MENU op tion in the main menu 4 5 1 Setup menu The SETUP menu is adapted to customize the CombiScan 500 according to your in dividual requirements or working methods By selecting this menu you can configure the communication with your host computer the built in printer and the printout format 13 14 including the result units the sensitivity of different pads etc
29. ochemistry system has been available for many years and allows qualitative or semi quantitative analysis within one minute by sim ple but careful observation The colour change occurring on each test pad of the strip is compared to a colour chart to obtain the result However misreading or misinterpreting of results caused by individual handling habits of the user or different light conditions may happen Urine analyzer urine strip reader equipment is designed specifically to improve the accuracy and security of urine strip evaluation by using light and photometric reader in order to detect the colour changes on the test strips The CombiScan 500 supports test data management and report generation by offering data storage and computerised data processing features The CombiScan 500 is a urine analyzer for professional use The reader is a semi auto matic benchtop instrument designed to read the CombiScreen 11SYS reagent strips The operator needs only to feed the equipment by placing the moisturised strip on the conveyor the rest as forwarding reading evaluating and disposal of the strips is done automatically by the device The timing route length and speed of the conveyor belt is adequate to the incubation time of the test strip The CombiScan 500 analyses the colour and intensity of the light reflected from the rea gent surface and reports the results in clinical meaningful units No further calculation is needed by the user Wh
30. of stored data to be transferred Enter the MENU MEMORY TRANSFER submenu and follow the steps below to transfer data E Use the control keys to select the first and the last item of the row to be transferred You can use the numeric keypad or external keyboard as well for entering the desired items E f you confirm the first item with the OK control key the curser automatically moves to the next position where you have to enter the last item of the memory range to be transferred After confirming the last item you automatically reach the next submenu where you can select the device to which you would like to send the data By pressing the PRINT control key the selected memory range will be printed out It will be send to a host if you press the SEND control key Sending the data require few seconds only After transmission has been done the display returns to MAIN MENU You can always leave the memory transfer option when pressing the QUIT function key 4 5 3 2 Clearing data from memory By using this option you can delete stored data At first you have to select the desired range Enter the MENU MEMORY CLEAR submenu and follow the steps below E Use the control keys to select the first and the last item of the row to be transferred You can use the in build keypad or external keyboard as well for entering the desired items 19 20 E f you confirm the first item with the OK contr
31. ol key the curser automatically moves to the next position where you have to enter the last item of the file to be deleted E After confirming the last item you automatically reach the next submenu where start deleting by pressing the OK control key If you press the BACK control key you will return to the previous menu where you can modify the selected range After clearing data from memory the CombiScan 500 returns to MAIN MENU You can always leave the memory clear option by pressing the QUIT key 4 6 Data download The results of measurements can be downloaded to a host computer by using the Com biScanner Data Management software You can find the software on the CD which is delivered together with the instrument IMPORTANT The data will be stored on a computer only if the measurement refers to a patient ID which has been added to the worklist see section 4 3 7 System requirements Hardware Processor Pentium 300Mhz Memory 256 MB RAM Hard disk 300 MB HDD Monitor 1024 768 color Software Windows XP Windows 2000 or Windows 98 Microsoft Internet Explorer 5 01 or higher Installation 1 Install the CombiScanner Data Management software on your computer Please care fully read the readme txt on CD first and follow the steps for software installation 2 Switch off the CombiScan 500 and connect it with a serial cable to the host computer Then switch on the instrument again 3
32. ol l mg dl 9 1 Ery ul Ery ul 29 Appendix Performance data Detection Limit Parameter Detection Limit Ascorbic acid 15 mg dl Bilirubin 0 6 mg dl Blood 6 8 Ery uL as Hb Glucose 40 50 mg dl Ketones 4 6 mg dl Leucocytes 10 15 Leu ul Nitrite 0 1 mg dl Protein 20 mg dl Urobilinogen 1 5 mg dl Since the concentration of normal urine constituents may vary between different sam ples the detection limit also may show variations Agreement to Reference Comparison 1 Comparison 2 Comparison 3 Comparison 4 Parameter same 1 same 1 same 1 same 1 colour colour colour colour colour colour colour colour block block block block block block block block Ascorbic acid 84 8 100 84 8 100 100 100 Bilirubin 68 8 100 93 8 100 86 7 99 6 100 100 92 0 100 98 2 100 90 7 100 100 100 Glucose 86 6 100 89 3 100 90 7 97 8 93 6 100 Ketones 83 0 100 93 8 99 1 92 9 99 1 100 100 Leucocytes 83 0 98 2 91 1 100 84 1 99 1 98 4 100 Nitrite 99 1 100 96 4 100 94 7 100 100 100 pH 90 2 100 60 7 99 1 64 2 100 100 100 Protein 86 6 100 94 6 100 82 3 9
33. sition Move the waste bin back into the CombiScan 500 and push it care fully until it locks in place with a click Results are not printed out The Printer is switched off The paper roll is inserted in the feeding slot in a wrong way Switch on the printer See section 4 5 1 1 1 Printer settings For loading a new paper roll refer to chapter 3 Installation 23 Technical data 24 8 Technical data methodology reflectance photometer detection CCD image processing max throughput 500 strip hour memory last 999 results display 4 x 24 character LCD printer 57 mm thermal printer 2 lines sec size 480 x 305 x 190 mm weight 10 kg external power adapter 7 5 VDC 3A Interfaces RS232 serial port AT PC keyboard interface DIN5 pole host communication keyboard barcode reader environment 15 30 C lt 85 rel atmospheric humidity Factory settings Date YYYY MM DD Time SS 24 hour mode Printer ON Sensitivity Default Pad Sequence Default Unit Conv Protocol PC unidir Speed 9600 Language English Memory Cleared List of spareparts consumables A93100 CombiScreen 11SYS pack size 100 pcs A94100 CombiScreen 11SYS Plus pack size 100 pcs A93010 Paper for thermal printer 67 mm x 25 m 56175x03 Rubber belt 1 pc 1A
34. tative results In special cases it may be nec essary to adjust the sensitivity of single parameters to special requirements of the user although it is not recommended by ANALYTICON To adjust the sensitivity enter MENU SETUP STRIP SENS submenu Pad measurement sensitivity can be set in two levels in both directions The set val ues on the display are as follows 2004 08 09 19 19 26 MENU SETUP STRIP UNIT SENS PADSEQ PAD SENSITIVITY DEFAULT USER DEFINE DEFAULT SET QUIT PAD SENSITIVITY PAD BIL SENSITIVITY 0 When SET option is selected the first PAD name with the actual setting is displayed After selecting the SET option the proper sensitivity of each test pad can be selected using the control keys To enter the selected sensitivity of a parameter and to jump to the next parameter press the NEXT key After having set the sensitivity the program will automati cally return to the previous function menu It is not possible to escape until all pad sensi tivities are set To skip a pad without any modifications just select NEXT To get back to MAIN MENU without changing the actual settings just press the QUIT function key To reset the settings adjusted by the manufacturer for all pads select the DEFAULT option Going back to MAIN MENU without changing the actual settings just press QUIT 15 16 IMPORTANT The adjustment of the pad sensitivity effects the results
35. the worklist ADD will appear on the display Now you can enter new items to the list If the number of worklist elements reaches the limit the FULL text will be displayed instead of the patient ID To get back to MAIN MENU select BACK option and than press the ENTER function key of the keypad To remove items from the worklist select CLEAR option In the WORKLIST CLEAR sub menu you can delete the whole worklist by selecting ALL or just delete individual items by pressing the ITEM control key There you can select the desired item using the control keys Pressing OK the item will be deleted go back to MAIN MENU press QUIT function key 4 4 Start The reader can evaluate only the CombiScreen 11SYS test strips There is a calibration card enclosed to the strips Each calibration card has an individual code This code au thorises the reader to read the strip To read more about calibration see section 4 5 2 2 Users should always follow the appropriate federal state and local guidelines concerning the use of external quality control materials There is no further special operation needed to calibrate the instrument before starting the daily routine urinalysis It is recommended to use urine controls at least daily to check the system It is possible to make measurements in sequence of samples or according to prepared worklist If a worklist is stored the reader WORKLIST is indicated in the START menu on the left s
36. ton material intact It is recommended to keep the packing materials for a while as well in case the instrument needs to be moved to another location or must be shipped to have it been repaired in the manufacturers service Check the packing list if the shipment is complete see section 2 1 If it is complete follow the instruction below otherwise please contact your distributor immediately m Place the CombiScan 500 to its working position Optional Connect the CombiScan 500 to your computers serial port by using the serial cable if necessary Optional Connect your keyboard or barcode reader optional to the interface connec tor Connect the power adapter first to DC connector then to the mains m Switch the reader by pressing ENTER on the built in keypad E In a few seconds the actual software version appears for a short moment on the LCD CLEAR MEMORY appears on the display m Press QUIT Now you reach the MAIN MENU m Select MENU by pressing the control key below the MENU sign m Select SERVICE by pressing the control key Select CLEAN by pressing the control key Now the door opens automatically and the conveyor section moves out until the cleaning position is reached Front Shaft Rear Shaft Install the cylinder 2 with the gear wheel onto the rear shaft until the built in magnet fixes it in the proper position see fig 4 Install the cylinder 1 onto the front shaft until the
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